Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

The genetic toxicity of 3, 5, 5-trimethylhexan1-ol was tested according to OECD TG 471 and 472 under GLP in bacterial test systems using S. thyphimurium (strains TA98, TA100, TA1535, TA1537) and E. coli strain Wp2 uvrA, in the absence or presence of induced rat liver 9000 supernatant for metabolic activation (S9 mix). The test substance did not increase the number of revertants, with or without meatbolic activation, when it was tested up to cytotoxic concentrations. Positive substances performed as expected. Therefore, the test material was not mutagenic (Shibuya-MHLW, 1997).

The same result was obtained in a supporting study where 3,5,5 -trimethylhexanol was tested according to OECD TG 471 under GLP conditions at concentrations up to 5000 µg/plate, or up to cytotoxic concentrations. The number of revertants was not increased in TA98, TA100, TA102, TA1535, and TA1537, with or without metabolic activation, in two independent experiments. Positive and negative controls were included and performed as expected. It is therefore concluded that 3,5,5 -trimethylhexanol was not mutagenic in bacteria (King, 1999). This study is also considered to be valid and suitable for assessment.

3, 5, 5,-trimethylhexan-1-ol was tested in an in-vitro mammalian cell chromosome aberration test according to OECD TG 473 under GLP conditions. Test concentrations ranged from 0.013 to 0.2 mg/mL. There was no clastogenic effect or polyploidy induced by the test substance at concentrations up to 0.1 mg/mL; the highest test concentration, 0.2 mg/mL, was highly cytotoxic. The test substance was therefore negative in this test (Tanaka-MHLW, 1997).


Short description of key information:
3,5,5-trimethyhexan-1-ol lacked genotoxicity in a valid Guideline studies, i.e. in an Ames test using S. typhimurium and E.coli test strains, and in a mammalian cell chromosome aberration test.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Regulation 67/548/EEC, Regulation 1272/2007/EC: no classification required